Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - livtencity

Document Subject

Generated Narrative: MedicinalProductDefinition mp2c250051417033f9ca5609b812b532b2

identifier: http://ema.europa.eu/identifier/EU/1/22/1672/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: LIVTENCITY 200 mg film-coated tablets.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-2c250051417033f9ca5609b812b532b2

identifier: http://ema.europa.eu/identifier/EU/1/22/1672/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - livtencity

Attesters

What is in this leaflet

1. What LIVTENCITY is and what it is used for
2. What you need to know before you take LIVTENCITY
3. How to take LIVTENCITY
4. Possible side effects
5. How to store LIVTENCITY
6. Contents of the pack and other information

LIVTENCITY is an antiviral medicine that contains the active substance maribavir. It is a medicine used to treat adults who have had an organ or bone marrow transplant and developed a CMV ( cytomegalovirus ) infection that did not go away or came back again after taking another antiviral medicine. CMV is a virus that a lot of people have without symptoms and normally just stays in the body without causing any harm. However, if your immune system is weakened after you get an organ or bone marrow transplant, you may be at higher risk of becoming ill from CMV.

Do not take LIVTENCITY

if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

if you take either of these medicines:* ganciclovir (used to manage CMV infection)* valganciclovir (used to manage CMV infection) You should not be given LIVTENCITY if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given LIVTENCITY. Warnings and precautions Talk to your doctor or pharmacist before taking LIVTENCITY if you are already being treated with cyclosporine, tacrolimus, sirolimus or everolimus (medicines to prevent transplant rejection). Additional blood tests may be needed to check the blood levels of these medicines. High levels of these medicines may cause serious side effects. Children and adolescents LIVTENCITY is not for use in children and adolescents under 18 years old. This is because LIVTENCITY has not been tested in this age group. Other medicines and LIVTENCITY Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because LIVTENCITY may affect the way other medicines work, and other medicines may affect how LIVTENCITY works. Your doctor or pharmacist will tell you if it is safe to take LIVTENCITY with other medicines. There are some medicines you must not take with LIVTENCITY. See list under Do not take LIVTENCITY . Also tell your doctor if you are taking any of the following medicines. This is because your doctor may have to change your medicines or change the dose of your medicines:

rifabutin, rifampicin for tuberculosis (TB) or related infections

St. John's wort (Hypericum perforatum) a herbal medicine for depression and sleep problems

statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin for high cholesterol

carbamazepine, phenobarbital, phenytoin usually for fits or seizures (epilepsy)

efavirenz, etravirine, nevirapine - used to treat HIV infection

antacid (aluminium and magnesium hydroxide oral suspension) for heartburn or indigestion due to excess stomach acid

famotidine for heartburn or indigestion due to excess stomach acid

digoxin heart medicine

clarithromycin antibiotic

ketoconazole and voriconazole for fungal infections

diltiazem heart medicine

dextromethorphan cough medicine

warfarin anticoagulant

oral contraceptive steroids for birth control

midazolam used as a sedative You can ask your doctor, pharmacist or nurse for a list of medicines that may interact with LIVTENCITY. Pregnancy If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. LIVTENCITY is not recommended in pregnancy. This is because it has not been studied in pregnancy and it is not known if LIVTENCITY will harm your baby while you are pregnant. Breast-feeding If you are breast-feeding or are planning to breast-feed, tell your doctor before taking this medicine. Breast-feeding is not recommended while taking LIVTENCITY. This is because it is not known if LIVTENCITY can pass into your breast milk or if this would affect your baby. Driving and using machines LIVTENCITY has no influence on your ability to drive or to use machines. LIVTENCITY contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. The recommended dose is 400 mg twice a day. That means you take two tablets of LIVTENCITY 200 mg in the morning, and another two tablets of 200 mg in the evening. You can take this medicine with or without food, as a whole tablet or a crushed tablet. If you take more LIVTENCITY than you should If you take too much LIVTENCITY, tell your doctor straight away. If you forget to take LIVTENCITY If you miss a dose, and there are less than 3 hours left until your next regular dose is due, then skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a forgotten dose. If you stop taking LIVTENCITY Even if you feel better, do not stop taking LIVTENCITY without talking to your doctor. Taking LIVTENCITY as recommended should give you the best chance of clearing CMV infection and/or disease. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Very common (may affect more than 1 in 10 people):

changes in the way things taste

feeling sick (nausea)

diarrhoea

being sick (vomiting)

tiredness (fatigue) Common (may affect up to 1 in 10 people):

Increased blood levels of medicines used to prevent transplant rejections

stomach (abdominal) pain

loss of appetite

headache

weight loss Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date that is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month. Do not store above 30 C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What LIVTENCITY contains

The active substance is maribavir. Each film-coated tablet contains 200 mg maribavir

The other ingredients (excipients) are

Tablet core:

Microcrystalline cellulose (E460(i)), Sodium starch glycolate (see section 2), Magnesium stearate (E470b)

Film coating:

Polyvinyl alcohol (E1203), Macrogol (i.e. polyethylene glycol) (E1521), Titanium dioxide (E171), Talc (E553b), Brilliant blue FCF aluminum lake (EU) (E133) What LIVTENCITY looks like and contents of the pack LIVTENCITY 200 mg film coated tablets are blue, oval shaped convex debossed with SHP on one side and 620 on the other side. The tablets are packaged in high-density polyethylene (HDPE) bottles with child resistant cap contains either 28, 56 or 112 (2 bottles of 56) film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HWIreland Manufacturer Takeda Ireland Limited Bray Business Park Kilruddery Co. Wicklow Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com Lietuva Takeda, UAB Tel: +370 521 09 medinfoEMEA@takeda.com

.: +359 2 958 27 medinfoEMEA@takeda.com Luxembourg/Luxemburg Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: + 420 234 722 medinfoEMEA@takeda.com Magyarorsz g Takeda Pharma Kft. Tel.: +36 1 270 7medinfoEMEA@takeda.com Danmark Takeda Pharma A/S Tlf: +45 46 77 10 medinfoEMEA@takeda.com Malta akeda HELLAS S.A. Tel: +30 210 6387medinfoEMEA@takeda.com Deutschland Takeda GmbH Tel: +49 (0)800 825 3medinfoEMEA@takeda.com Nederland Takeda Nederland B.V. Tel: +31 20 203 5medinfoEMEA@takeda.com Eesti Takeda Pharma AS Tel: +372 6177 medinfoEMEA@takeda.com Norge Takeda AS Tlf: +47 800 800 medinfoEMEA@takeda.com

akeda . . T : +30 210 6387medinfoEMEA@takeda.com sterreich Takeda Pharma Ges.m.b.H. Tel: +43 (0) 800-20 80 medinfoEMEA@takeda.com Espa a Takeda Farmac utica Espa a S.A. Tel: +34 917 90 42 medinfoEMEA@takeda.com Polska Takeda Pharma Sp. z o.o. Tel.: +48223062medinfoEMEA@takeda.com France Takeda France SAS T l: + 33 1 40 67 33 medinfoEMEA@takeda.com Portugal Takeda Farmac uticos Portugal, Lda. Tel: + 351 21 120 1medinfoEMEA@takeda.com Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 medinfoEMEA@takeda.com Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 medinfoEMEA@takeda.com Ireland Takeda Products Ireland Ltd Tel: 1800 937 medinfoEMEA@takeda.com Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o. Tel: + 386 (0) 59 082 medinfoEMEA@takeda.com sland Vistor hf. S mi: +354 535 7medinfoEMEA@takeda.com Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 medinfoEMEA@takeda.com Italia Takeda Italia S.p.A. Tel: +39 06 502medinfoEMEA@takeda.com Suomi/Finland Takeda Oy Puh/Tel: 0800 774 medinfoEMEA@takeda.com

akeda . . .: +30 210 6387medinfoEMEA@takeda.com Sverige Takeda Pharma AB Tel: 020 795 medinfoEMEA@takeda.com Latvija Takeda Latvia SIA Tel: +371 67840medinfoEMEA@takeda.com United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 medinfoEMEA@takeda.com This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: